Back to resultsPreservative-Free Tafluprost (MK-2452) for the Treatment of Open-Angle Glaucoma or Ocular Hypertension (MK-2452-002)
Primary Purpose
Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Preservative-Free Tafluprost or vehicle
Preservative-Free Timolol maleate
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring Tafluprost, Glaucoma, Ocular Hypertension, Timolol, Eye Disorder, Preservative-Free, Prostaglandin Analogue
Eligibility Criteria
Inclusion Criteria:
- Participant has been diagnosed with primary open-angle glaucoma, pigmentary glaucoma, capsular glaucoma/pseudoexfoliation, or ocular hypertension
- Has been using ocular hypotensive medication on a stable treatment regimen for at least 30 days prior to screening, or is treatment-naive (has never used or has not used ocular hypotensive medication for the last 4 weeks prior to screening)
- Able to discontinue all topical and/or systemic ocular hypotensive medication during the washout period (up to 4 weeks pre-study)
- Best-corrected early treatment of diabetic retinopathy study (ETDRS) visual acuity of 20/80 or better in each eye
- Willing and able to avoid wearing contact lenses from 4 weeks prior to dosing with study medication through 24 hours after final dosing
- Willing and able to self-administer or has an able person available on a daily basis to assist with administration of study medications
- Participant with reproductive potential must agree to remain abstinent (unless abstinence is not a locally acceptable method of contraception) or use highly effective methods of birth control (hormonal contraceptives, intrauterine device, diaphragm, condoms and vasectomy) within the projected duration of the study
- Able to refrigerate study drug at home.
Exclusion Criteria:
- Mean IOP >36 mmHg in either eye at screening
- Unable to use study medication in the affected eye(s)
- History of any inflammatory ocular surface disease or a history of anterior or posterior uveitis in either eye within 6 months prior to screening
- History of retinal detachment, proliferative diabetic retinopathy, or any progressive retinal disease
- Significant visual field loss or evidence of progressive visual loss within the last year
- Intraocular surgery in either eye in the last 4 months
- Any glaucoma surgery, refractive surgery, or penetrating keratoplasty in either eye
- Currently on two or more anti-glaucoma medications (except Cosopt™ or its generic formulation)
- Previously used tafluprost
- History of cardiovascular disorder within 6 months of screening
- History of bronchial asthma, wheezing, chronic obstructive pulmonary disease (COPD) or other pulmonary disease, abnormal chest x-ray, or has current active pneumonia.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tafluprost
Timolol
Arm Description
One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks. Morning dose with vehicle only allows blinding to match twice daily dosing of comparator arm.
One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
Outcomes
Primary Outcome Measures
Mean Diurnal IOP Change From Baseline at Week 4 - Study Eye
IOP was measured at baseline, Week 2 and Week 4 using a Goldmann applanation tonometer. At each of these visits, IOP measurement was performed at 0800, 1000 and 1600 hours. At each IOP assessment time point during a visit, 2 consecutive IOP measurements were made. If these 2 measurements differed by ≤2 mmHg, then the average of the 2 IOP values was recorded. If the 2 measurements differed by >2 mmHg, then a third measurement was obtained and the median of these 3 measurements was recorded. The IOP value for a visit (e.g., Week 4) was the mean of the values recorded at the 3 time points during the visit. For each participant, one "study eye" was identified for data summarization and analysis for this primary efficacy outcome measure. The "study eye" was the eye with the higher (i.e., "worse") IOP at baseline, or if both eyes had the same baseline IOP value, the right eye was designated the "study eye." Change from baseline in IOP at Week 4 = Week 4 IOP value - baseline IOP value.
Number of Participants With an Adverse Event (AE)
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants with one or more AEs during the study are counted once in this summary.
Number of Participants Who Discontinued Study Drug Due to an AE
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants who discontinued study drug treatment due to an AE are counted once in this summary.
Secondary Outcome Measures
Number of Participants With ≥25% Reduction in IOP From Baseline to Week 4 - Study Eye
IOP was measured at baseline, Week 2 and Week 4 using a Goldmann applanation tonometer. At each of these visits, IOP measurement was performed at 0800, 1000 and 1600 hours. At each IOP assessment time point during a visit, 2 consecutive IOP measurements were made. If these 2 measurements differed by ≤2 mmHg, then the average of the 2 IOP values was recorded. If the 2 measurements differed by >2 mmHg, then a third measurement was obtained and the median of these 3 measurements was recorded. The IOP value for a visit (e.g., Week 4) was the mean of the values recorded at the 3 time points during the visit. For each participant, one "study eye" was identified for data summarization and analysis. The "study eye" was the eye with the higher (i.e., "worse") IOP at baseline, or if both eyes had the same baseline IOP value, the right eye was designated the "study eye." Percent reduction in IOP at Week 4 = ([baseline IOP value - Week 4 IOP value]/Baseline IOP value)*100.
Full Information
NCT ID
NCT01254604
First Posted
December 3, 2010
Last Updated
August 21, 2018
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01254604
Brief Title
Preservative-Free Tafluprost (MK-2452) for the Treatment of Open-Angle Glaucoma or Ocular Hypertension (MK-2452-002)
Official Title
A Phase III, Randomized, Active Comparator-Controlled, Four-Week, Double-Masked Clinical Trial to Compare the Efficacy and Safety of Preservative-Free MK-2452 (0.0015%) and Preservative-Free Timolol Maleate (0.5%) in Patients With Open-Angle Glaucoma or Ocular Hypertension in India
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2011 (Actual)
Primary Completion Date
May 9, 2013 (Actual)
Study Completion Date
May 9, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will test the hypothesis that preservative-free tafluprost (MK-2452) is non-inferior to preservative-free timolol maleate with respect to the diurnal intraocular pressure (IOP) change from baseline after 4 weeks of therapy in participants with open-angle glaucoma or ocular hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension
Keywords
Tafluprost, Glaucoma, Ocular Hypertension, Timolol, Eye Disorder, Preservative-Free, Prostaglandin Analogue
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tafluprost
Arm Type
Experimental
Arm Description
One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks. Morning dose with vehicle only allows blinding to match twice daily dosing of comparator arm.
Arm Title
Timolol
Arm Type
Active Comparator
Arm Description
One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
Intervention Type
Drug
Intervention Name(s)
Preservative-Free Tafluprost or vehicle
Other Intervention Name(s)
MK-2452
Intervention Description
Preservative-free tafluprost (0.0015%) ophthalmic solution; Preservative-free vehicle ophthalmic solution (contains no active drug)
Intervention Type
Drug
Intervention Name(s)
Preservative-Free Timolol maleate
Other Intervention Name(s)
Preservative-Free Timoptic
Intervention Description
Preservative-free timolol maleate (0.5%) ophthalmic solution
Primary Outcome Measure Information:
Title
Mean Diurnal IOP Change From Baseline at Week 4 - Study Eye
Description
IOP was measured at baseline, Week 2 and Week 4 using a Goldmann applanation tonometer. At each of these visits, IOP measurement was performed at 0800, 1000 and 1600 hours. At each IOP assessment time point during a visit, 2 consecutive IOP measurements were made. If these 2 measurements differed by ≤2 mmHg, then the average of the 2 IOP values was recorded. If the 2 measurements differed by >2 mmHg, then a third measurement was obtained and the median of these 3 measurements was recorded. The IOP value for a visit (e.g., Week 4) was the mean of the values recorded at the 3 time points during the visit. For each participant, one "study eye" was identified for data summarization and analysis for this primary efficacy outcome measure. The "study eye" was the eye with the higher (i.e., "worse") IOP at baseline, or if both eyes had the same baseline IOP value, the right eye was designated the "study eye." Change from baseline in IOP at Week 4 = Week 4 IOP value - baseline IOP value.
Time Frame
Baseline and Week 4
Title
Number of Participants With an Adverse Event (AE)
Description
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants with one or more AEs during the study are counted once in this summary.
Time Frame
Up to 14 days after Week 4 visit
Title
Number of Participants Who Discontinued Study Drug Due to an AE
Description
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants who discontinued study drug treatment due to an AE are counted once in this summary.
Time Frame
Up to Week 4
Secondary Outcome Measure Information:
Title
Number of Participants With ≥25% Reduction in IOP From Baseline to Week 4 - Study Eye
Description
IOP was measured at baseline, Week 2 and Week 4 using a Goldmann applanation tonometer. At each of these visits, IOP measurement was performed at 0800, 1000 and 1600 hours. At each IOP assessment time point during a visit, 2 consecutive IOP measurements were made. If these 2 measurements differed by ≤2 mmHg, then the average of the 2 IOP values was recorded. If the 2 measurements differed by >2 mmHg, then a third measurement was obtained and the median of these 3 measurements was recorded. The IOP value for a visit (e.g., Week 4) was the mean of the values recorded at the 3 time points during the visit. For each participant, one "study eye" was identified for data summarization and analysis. The "study eye" was the eye with the higher (i.e., "worse") IOP at baseline, or if both eyes had the same baseline IOP value, the right eye was designated the "study eye." Percent reduction in IOP at Week 4 = ([baseline IOP value - Week 4 IOP value]/Baseline IOP value)*100.
Time Frame
Baseline and Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant has been diagnosed with primary open-angle glaucoma, pigmentary glaucoma, capsular glaucoma/pseudoexfoliation, or ocular hypertension
Has been using ocular hypotensive medication on a stable treatment regimen for at least 30 days prior to screening, or is treatment-naive (has never used or has not used ocular hypotensive medication for the last 4 weeks prior to screening)
Able to discontinue all topical and/or systemic ocular hypotensive medication during the washout period (up to 4 weeks pre-study)
Best-corrected early treatment of diabetic retinopathy study (ETDRS) visual acuity of 20/80 or better in each eye
Willing and able to avoid wearing contact lenses from 4 weeks prior to dosing with study medication through 24 hours after final dosing
Willing and able to self-administer or has an able person available on a daily basis to assist with administration of study medications
Participant with reproductive potential must agree to remain abstinent (unless abstinence is not a locally acceptable method of contraception) or use highly effective methods of birth control (hormonal contraceptives, intrauterine device, diaphragm, condoms and vasectomy) within the projected duration of the study
Able to refrigerate study drug at home.
Exclusion Criteria:
Mean IOP >36 mmHg in either eye at screening
Unable to use study medication in the affected eye(s)
History of any inflammatory ocular surface disease or a history of anterior or posterior uveitis in either eye within 6 months prior to screening
History of retinal detachment, proliferative diabetic retinopathy, or any progressive retinal disease
Significant visual field loss or evidence of progressive visual loss within the last year
Intraocular surgery in either eye in the last 4 months
Any glaucoma surgery, refractive surgery, or penetrating keratoplasty in either eye
Currently on two or more anti-glaucoma medications (except Cosopt™ or its generic formulation)
Previously used tafluprost
History of cardiovascular disorder within 6 months of screening
History of bronchial asthma, wheezing, chronic obstructive pulmonary disease (COPD) or other pulmonary disease, abnormal chest x-ray, or has current active pneumonia.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
27292765
Citation
Chabi A, Baranak C, Lupinacci R, Herring WJ. Preservative-free tafluprost in the treatment of open-angle glaucoma or ocular hypertension in India: a phase III clinical trial. Int J Clin Pract. 2016 Jul;70(7):577-86. doi: 10.1111/ijcp.12815. Epub 2016 Jun 13.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/study.html?id=2452-002&kw=2452-002&tab=access
Learn more about this trial
Preservative-Free Tafluprost (MK-2452) for the Treatment of Open-Angle Glaucoma or Ocular Hypertension (MK-2452-002)
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